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Heb solutions sunscreen - Medication Information

Product NDC Code 37808-951
Drug Name

Heb solutions sunscreen

Type Brand
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 150 mg/ml
Octisalate 50 mg/ml
Octocrylene 100 mg/ml
Oxybenzone 60 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name H.E.B
Packages
Package NDC Code Description
37808-951-09 89 ml in 1 tube (37808-951-09)
37808-951-12 237 ml in 1 tube (37808-951-12)
37808-951-79 308 ml in 1 tube (37808-951-79)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions apply liberally 15 minutes before sun exposure reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10am-2pm • wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient(s) water, propylene glycol, styrene/acrylates copolymer, silica, aluminum starch octenylsuccinate, behenyl alcohol, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, butylated PVP, disodium EDTA, butylene glycol

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses • Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
HEB Solutions Sunscreen Sport SPF 100 Lotion PODOPHYLLUM PELTATUM ROOT LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE WATER PROPYLENE GLYCOL SILICON DIOXIDE ALUMINUM STARCH OCTENYLSUCCINATE DOCOSANOL GLYCERYL MONOSTEARATE MICROCRYSTALLINE CELLULOSE BENZYL ALCOHOL PALMITIC ACID MYRISTYL ALCOHOL STEARIC ACID LAURYL ALCOHOL CETYL ALCOHOL ALOE VERA LEAF CHAMOMILE .ALPHA.-TOCOPHEROL, DL- LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM CHLORPHENESIN EDETATE DISODIUM BUTYLENE GLYCOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OXYBENZONE OXYBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
HEB56576A HEB53469A Label

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Stop use and ask doctor if • rash occurs

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use • on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information protect the product in this container from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API